Prescription medicine
Luliconazole Brand names: Luzu
Luliconazole (Luzu) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the luliconazole FDA label on DailyMed (effective April 1, 2020, Bausch Health US, LLC); the NDA 204153 record on Drugs@FDA; every luliconazole label on DailyMed.
Highlights of the record
FDA label of April 1, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.
Forms and strengths
- 10 mg/g
Cream.
On the market
- Earliest approval on file
- November 14, 2013 Luzu, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 28, 2034 Luzu cream; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 168 through July 30, 2026
What is luliconazole used for?
From the label: indications and usageLUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.
Conditions named in the indications of luliconazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (Luzu), Bausch Health US, LLC, effective April 1, 2020 (SPL set a7016010-ce43-4c09-8d21-aeb697ffed31), via openFDA; the full label on DailyMed
Is there a generic for luliconazole (Luzu)?
No generic luliconazole is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Luzu cream: the compound patent runs to September 6, 2033, and the last listed entry to April 28, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for luliconazole?
The FDA Adverse Event Reporting System holds 168 reports that list luliconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 81 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as luliconazole?
18 other medicines are given the same way (topical) and in the same FDA class as luliconazole or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clotrimazole | Fungal infections | 13 labelers | $0.133 per gram 1% topical cream | No current entry |
| Miconazole | Fungal infections | none listed | $0.120 per gram 2% topical cream | No current entry |
| Ketoconazole | Fungal infections | 25 labelers | $0.249 per gram 2% cream | No current entry |
| Betamethasone and clotrimazole | Fungal infections | 16 labelers | $0.190 per gram Clotrimazole-betamethasone cream | No current entry |
| Econazole | Fungal infections | 6 labelers | $0.351 per gram 1% cream | No current entry |
| Sulconazole | Fungal infections | none listed | n/a | A presentation being discontinued |
| Oxiconazole | Fungal infections | 1 labeler | $3.92 per gram 1% cream | No current entry |
| Miconazole and petrolatum and zinc oxide | Fungal infections | none listed | $9.12 per gram 0.25-15% | No current entry |
Every medicine labeled for the same conditions as luliconazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to luliconazole
- 18 medicines for the same use
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Luliconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other